MedPath
FDA Product

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

55045-1194

Regulatory Information

55045-1194

ANDA064047

C73584

November 7, 2011

USA

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

066070785

Active Ingredients

POLYMYXIN B SULFATE

Quantity: 10000 [USP'U] in 1 mL

Code: 19371312D4

Class Code: ACTIM

NEOMYCIN SULFATE

Quantity: 1.75 mg in 1 mL

Code: 057Y626693

Class Code: ACTIM

GRAMICIDIN

Quantity: 0.025 mg in 1 mL

Code: 5IE62321P4

Class Code: ACTIB

Sodium Chloride

Code: 451W47IQ8X

Class Code: IACT

Alcohol

Code: 3K9958V90M

Class Code: IACT

Poloxamer 188

Code: LQA7B6G8JG

Class Code: IACT

Hydrochloric Acid

Code: QTT17582CB

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

POLYMYXIN B

Code: J2VZ07J96K

NEOMYCIN

Code: I16QD7X297

GRAMICIDIN

Code: 5IE62321P4

© Copyright 2025. All Rights Reserved by MedPath